Dr. Willenberg has owned Kelly Willenberg & Associates for twelve years. Kelly has extensive knowledge in clinical trials management and research compliance, including all aspects of clinical trial billing compliance. She has over 35 years of clinical research experience. She has a Bachelors Degree in Nursing, with a Masters and a Doctorate in Business Administration. She is an experienced oncology nurse with the majority of her experience in oncology, pediatrics, school nursing and cardiac rehab. Kelly worked for over twelve years at Vanderbilt University Medical Center. She established the enterprise wise billing compliance program at Vanderbilt and served as the first Director of Billing Compliance in 2002. She also served as the Director of the Clinical Trials Office for the Cancer Center managing a Community Oncology Research Program (CCOP) and an affiliate network throughout the southeast while at Vanderbilt and was an active member of the nursing committees in the cooperative groups with NCI.
Kelly is a frequent presenter and speaker at the ONS, ASCO, AHIA, MAGI, SoCRA, ACRP, SCRS and other professional organizations. She served as the managing editor for the 3rd Edition of the Research Compliance Professionals Handbook for HCCA. She served as an editor for the 3rd Edition of the Manual for Clinical Trials Nurses for ONS. She has a bi-monthly column in Compliance Today titled "Research Reflections". She is a Certified Clinical Research Professional (CCRP), Certified as a Healthcare Research Compliance Professional (CHRC) and Certified in Healthcare Compliance (CHC). She is a faculty member of the Research Compliance Academy and serves on the Board of Directors for SCCE & HCCA. Kelly serves at the national level for UNOS on the Lung Transplantation Committee. She was appointed by the Governor of SC on the Small Business Regulatory Review Committee. She has a podcast series called Kelly to the Core, and works at the state and national level on advocacy in distracted driving, funding for research, nursing and payer issues, and drug parity.